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| ID | Type | Description | Link |
|---|---|---|---|
| K22CA237639 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmokefreeSGM | Experimental |
| |
| SmokefreeTXT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmokefreeSGM | Behavioral | Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by Number of Participants Recruited for the Study | Baseline | |
| Feasibility as Assessed by Number of Participants That Completed Month 1 Visit | end of month 1 | |
| Feasibility as Assessed by Number of Participants That Completed Month 3 Visit | end of month 3 | |
| Feasibility as Assessed by Number of Participants That Completed Month 6 Visit | end of month 6 | |
| Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews | 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Quit Smoking | 1 month follow up | |
| Number of Participants That Quit Smoking | 3 month follow up | |
| Number of Participants That Quit Smoking |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as a lesbian, gay, bisexual, transgender or queer individual
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| Name | Affiliation | Role |
|---|---|---|
| Irene Tami-Maury, DMD, DrPH, MSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41306822 | Derived | Tundealao S, Oubda MC, Klaff R, Reininger B, McNeill L, Tami-Maury I. Pragmatic recruitment strategies for a text-based smoking cessation intervention for sexual and gender minority groups. Discov Public Health. 2025;22(1):743. doi: 10.1186/s12982-025-01117-0. Epub 2025 Nov 24. |
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Of the 217 participants screened, 100 participants met all inclusion criteria, were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | SmokefreeSGM | SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers. |
| FG001 | SmokefreeTXT | SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SmokefreeTXT | SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population |
| BG001 | SmokefreeSGM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Assessed by Number of Participants Recruited for the Study | Posted | Count of Participants | Participants | Baseline |
|
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SmokefreeSGM | SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Tami-Maury, DMD,MSc,DrPH-NHSN | The University of Texas Health Science Center at Houston | 713-500-9234 | Irene.M.Tami-Maury@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2023 | Jul 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2023 | Jul 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D018452 | Homosexuality, Female |
| D006716 | Homosexuality |
| D001727 | Bisexuality |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
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| SmokefreeTXT | Behavioral | Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population |
|
| 6 month follow up |
SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Work Status | Count of Participants | Participants |
|
| Level of Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Children in household | Count of Participants | Participants |
|
| Number of Participants who live with other smokers | Count of Participants | Participants |
|
| Number of times participants tried to quit smoking | Count of Participants | Participants |
|
| Age at smoking initation | Mean | Standard Deviation | years |
|
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence | The Fagerström Test for Nicotine Dependence (FTND) is a standard instrument for assessing the intensity of physical addiction to nicotine. The total score ranges from 0 to 10. Participants were categorized as mild (between 0 and 3), moderate(between 4 and 6) or severe (greater than 7) nicotine dependence based on their FTND score. | Count of Participants | Participants |
|
| E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index | The Penn State E-cigarette Dependence Index is a standard instrument for assessing e-cigarette dependence. The total score ranges from 0 to 20. Participants were categorized as Not dependent (between 0 and 3), Low dependence (between 4 and 8), medium dependence (between 9 and 12, or high dependence (greater than 13) based off their score. | Data for this outcome measure was collected for only the participants who smoke electronic cigarettes. | Count of Participants | Participants |
|
| Number of participants who smoke electronic cigarettes | Count of Participants | Participants |
|
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| Primary | Feasibility as Assessed by Number of Participants That Completed Month 1 Visit | Posted | Count of Participants | Participants | end of month 1 |
|
|
|
| Primary | Feasibility as Assessed by Number of Participants That Completed Month 3 Visit | Posted | Count of Participants | Participants | end of month 3 |
|
|
|
| Primary | Feasibility as Assessed by Number of Participants That Completed Month 6 Visit | Posted | Count of Participants | Participants | end of month 6 |
|
|
|
| Primary | Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews | Posted | Count of Participants | Participants | 6 months follow up |
|
|
|
| Secondary | Number of Participants That Quit Smoking | Posted | Count of Participants | Participants | 1 month follow up |
|
|
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| Secondary | Number of Participants That Quit Smoking | Posted | Count of Participants | Participants | 3 month follow up |
|
|
|
| Secondary | Number of Participants That Quit Smoking | Posted | Count of Participants | Participants | 6 month follow up |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | SmokefreeTXT | SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population | 0 | 50 | 0 | 50 | 1 | 50 |
| Palpitations | General disorders | Non-systematic Assessment |
|
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| Hispanic |
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| Other |
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| Others (pansexual, queer, unsure) |
|
| Bachelor's/ master's /associate degree |
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| More than 10 times |
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| severe dependance on nicotine |
|
| medium dependence |
|
| high dependence |
|